Alpha 1-AntitrypsinPhase 4IgG in AATDNCT07135427
Genetic Variation in IgG in Alpha 1 Antitrypsin Deficiency
A Phase 4 study testing 20-valent pneumococcal conjugate vaccine in people with Alpha 1-Antitrypsin and COPD, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The goal of this study is to learn whether patients who have a genetic mutation in the genes that cause alpha 1 antitrypsin deficiency also have genetic variation in nearby genes that can increase risk for reduced immune function and respiratory infections. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alpha 1-Antitrypsin, COPD, Antibody Deficiency
- What is being tested?
- 20-valent pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2025to Jun 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults who are heterozygous for a SERPINA1 Z allele
- Have either had no COPD exacerbations or 2 or more exacerbations in the previous year
- Has not received a pneumococcal conjugate vaccine within the past 5 years, or has only received the pneumococcal polysaccharide vaccine in the past
Who cannot join
- Received a pneumococcal conjugate vaccine within the past 5 years
- Known allergy, severe adverse reaction, or other sensitivity to pneumococcal conjugate vaccines
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
LaFon, 2059343411, dlafon@uabmc.edu
David C LaFon, MD
About this study
Official title: Genetic Variation in IgG as a Mechanism for Immune Deficiency and Exacerbations in AATD
The goal of this study is to learn whether patients who have a genetic mutation in the genes that cause alpha 1 antitrypsin deficiency also have genetic variation in nearby genes that can increase risk for reduced immune function and respiratory infections.
To investigate this hypothesis, we will compare immune responses to the 20-valent pneumococcal conjugate vaccine (PCV20, Pfizer) between participants who have one abnormal copy of the SERPINA1 gene and either no COPD exacerbations, vs those with 2 or more COPD exacerbations in the past year.
- Conditions
- Alpha 1-Antitrypsin, COPD, Antibody Deficiency
- Being tested
- 20-valent pneumococcal conjugate vaccine
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20-valent pneumococcal conjugate vaccineBiological
Administration of PCV20
| Study group | Role | What they receive |
|---|---|---|
| SERPINA1 'Z' heterozygotes | Experimental | Participants who are heterozygous for the SERPINA1 'Z' allele with either 0 or 2+ exacerbations in the previous year, and have not received pneumococcal vaccination within 5 years will be given PCV20. Receives: Biological: 20-valent pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response
Pneumococcal antibody levels/function, total IgG levels, IgG subclass levels; magnitude of change from baseline
Measured: 4 weeks from baseline measurement
Secondary outcomes (1)
Lymphocyte profile
B and T cell lymphocyte subsets
Measured: Baseline, 4 weeks post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start3 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha 1-AntitrypsinStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Alpha-1 Foundation
- Responsible party
- Principal investigator, David Lafon, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135427
- Sponsor's protocol ID
- IRB300008528(000547878)
- Other IDs
- Research award
- Acronym
- IgG in AATD
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided